Kornimate/medical-research-clean huggingface dataset:
energy expenditure, diet and body fat in children

Conditions: Cardiovascular Diseases; Heart Diseases; Obesity

Summary: to characterize the pattern of change over a two year period in energy expenditure and energy intake in two cohorts of american indian (ai) children.

background: obesity is highly prevalent in american indian children, increasing their risk for the development of cardiovascular disease, hypertension and diabetes. although increasing energy expenditure, through increasing physical activity, and decreasing dietary fat intake should slow the rate of body fat gain, it appears that children actually decrease their physical activity as they mature from pre-to post-pubescence. several studies have shown that the decline in activity is greater in females than in males, and greater in non-whites than in whites; however, other studies have not supported these findings. further, there were no data available in american indian children, which is a population at greatest risk. additionally, inconsistencies have been reported with respect to the relationship between body weight or body fat and energy intake or dietary fat intake. at the heart of the problem is the difficulty in measuring self-reported physical activity and dietary intake accurately. accurate self- report measures are necessary for use in the large scale studies that are required to investigate relationships between physical activity and dietary intake and disease. the healthy people 2000: national health promotion and disease prevention objectives include seven objectives emphasizing increasing physical activity in children and adolescents. design narrative: this study had a combined longitudinal and cross-sectional design in which the investigators modified the best existing methods for the self-report of physical activity and dietary intake in children and adolescents, and evaluated their validity using total energy expenditure (tee) measured by doubly labeled water (dlw) as the criterion. they then used these methods to measure physical activity and dietary intake in two age cohorts of male and female american indian children (8-10-years and 11-13-years) at baseline and two years later, with two sets of interim measurements. change in tee from baseline to the two-year follow-up was also measured using dlw and the tritrac accelerometer. equations for the estimation of percent body fat were cross-validated for this population. the study filled an existing gap by improving existing instruments for the measurement of physical activity and dietary intake in children and adolescents, and provided longitudinal data on change in these variables in the same children over time, plus provided cross-sectional data for each age and gender group to compare to the existing literature. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
safety and pharmacokinetics of odm-204 in patients with metastatic castration-resistant prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this first-in-man study is to evaluate safety, tolerability and pharmacokinetics of odm-204 in patients with metastatic castration-resistant prostate cancer.

the safety profile of odm-204 will be explored together with the pharmacokinetics, pharmacodynamics and tumour response to treatment with odm-204 to recommend the dosing regimen for further clinical studies. the pharmacokinetic properties of odm-204 will be evaluated after single and multiple dose administrations at different dose levels.

Eligibility criteria:
inclusion criteria: * written informed consent (ic) obtained. * male aged ≥ 18 years. * histologically or cytologically confirmed adenocarcinoma of prostate. * ongoing gnrh agonist or antagonist therapy, or after bilateral orchiectomy. * progressive metastatic disease * adequate bone marrow, hepatic, and renal function * acceptable and regular bowel movements without any gi disorder or procedure which may interfere with absorption of study treatment * ability to swallow study treatments exclusion criteria: * history of pituitary or adrenal dysfunction. * known brain metastases. * active infection or other medical condition that would make prednisone (corticosteroid) contraindicated. * uncontrolled hypertension * clinically significant heart disease * prolonged qtc interval
bioequivalency study of amlodipine tablets under fasting conditions

Conditions: Hypertension; Chronic Stable Angina; Vasospastic Angina

Summary: the objective of this study was the bioequivalence of a roxane laboratories' amlodipine besylate tablets, 10 mg, to norvasc® tablets, 10 mg (pfizer) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. * treatment with known enzyme altering drugs. * history of allergic or adverse response to amlodipine besylate or any comparable or similar product.
cross-cultural differences in the network structure of social anxiety and body dysmorphic symptoms

Conditions: Depression; Anxiety; Body Dysmorphic Disorders

Summary: this study will examine cross-cultural differences in the network structure of social anxiety and body dysmorphic symptoms across germany, the united states, and japan.

this study will investigate the network structure of social anxiety, body dysmorphic symptoms, depressive symptoms, and shame across germany, the united states, and japan. social anxiety disorder and body dysmorphic disorder frequently co-occur and share several clinical features beyond fear of negative evaluation (coles et al., 2006; dietel et al., 2021; fang et al., 2011). both conditions have also been found to exhibit high comorbidity with major depressive disorder (acarturk et al., 2008; grant et al., 2005; gunstad \& phillips, 2003; phillips et al., 1998). cognitive-behavioral therapy targeting social anxiety disorder or body dysmorphic disorder has been shown to significantly alleviate depressive symptoms (e.g., enander et al., 2016; noda et al., 2023; ritter et al., 2023). shame has also been implicated in the development of depressive symptoms, as well as social anxiety disorder and body dysmorphic disorder (kim et al., 2011). comparing the symptom networks of social anxiety, body dysmorphic symptoms, and depression-and identifying central symptoms within each cultural context-may contribute to the development of transdiagnostic treatments with cross-cultural applicability.

Eligibility criteria:
inclusion criteria: * german, american, and japanese citizens over 18 years old. exclusion criteria: * individuals who do not obtain consent

Keywords: cross-cultural study
a treatment with fulvestrant and exemestane in postmenopausal patients with advanced hormone receptor-positive (hr) + breast cancer

Conditions: Postmenopause; Breast Cancer

Summary: for patients receiving faslodex 500 mg, to compare the effectiveness in terms of time to progression (ttp) as a function of the line of treatment (i.e. 1st vs. 2nd vs. 3rd line). for all patients, to collect and explore real-life data on the epidemiology and management of pseudomyxoma peritonea (pmp) patients with hr+ advanced breast cancer (abc) treated with faslodex 500 mg or exemestane.


Eligibility criteria:
inclusion criteria: * signed written informed consent * female postmenopausal patient (or patient post-ovariectomy) and age ≥18 years postmenopause ist defined as * age ≥ 60 years and natural menopause with menses \> 1year ago or * fsh and e2 levels in the postmenopausal range or * patients who had bilateral ovariectomy (nccn v.i. 2009) * histologically confirmed er+ locally advanced or metastatic breast cancer * not eligible for curative therapy * prior treatment with tamoxifen * suitable to undergo endocrine treatment for er+ abc with serd / sai * patient is able to read and understand german exclusion criteria: * known hypersensitivity to faslodex or exemestane or any compounds of the drugs * prior treatment with faslodex 500 mg or faslodex 250 mg\* * for patients who receive treatment with faslodex 500 mg within this observational study. patients who are included in the exemestane arm may have received prior faslodex treatment. * prior treatment with exemestane for patients who receive treatment with exemestane within this observational study * acutely life threatening disease * treatment with faslodex 250 mg/month (previously approved dose) * prior palliative chemotherapy

Keywords: fulvestrant exemestane postmenopausal patients advanced hr+ breast cancer hormone receptor positive advanced breast cancer
metformin in patients with non-alcoholic fatty liver disease (nafld)

Conditions: Liver Diseases

Summary: the purpose of this study is to examine the effect of metformin on biochemical and histological findings in nafld patients with insulin resistance syndrome.

study population: 30 patients will be included who meet all the following criteria: alt \> 2 times normal range; liver histology revealing nash (type 2-4), without cirrhosis; clinical characteristics of the metabolic syndrome as defined by the ncep, but no overt diabetes; negative work-up for other causes of liver diseases including alcohol intake \< 40 g/week. all patients will undergo liver biopsy and only patients with type 2-4 (steatosis + inflammation, or steatosis plus ballooning degeneration, or steatosis plus fibrosis and/or mallory bodies) but without cirrhosis will be included. patients who received lipid lowering medications or anti hypertensive drugs prior to study will continue the treatment. patients who will develop overt type 2 dm with hbaic \> 7% during study will be withdrawn. intervention: all patients will have dietary intervention by a dietician and will be encouraged to increase physical activity. patients will be receiving metformin 850 mg tid for 12 months. outcome: * improvement of liver enzymes (alt, ast, ggt) * improvement of metabolic profile: lipid profile, fasting and post-load glucose and insulin levels, homa. * liver histology (repeated liver biopsy after 1 year). * soluble tnf receptors- tnf-receptor p55 and p75.

Eligibility criteria:
inclusion criteria: * alt \> 2 times normal range. * liver histology revealing non-alcoholic steatohepatitis \[nash\] (type 2-4), without cirrhosis. * clinical characteristics of the metabolic syndrome as defined by the national cholesterol education program (ncep), but no overt diabetes. * negative work-up for other causes of liver diseases including alcohol intake \< 40 g/week. exclusion criteria: * diabetes mellitus. * alcohol intake \> 40 g per week.

Keywords: non-alcoholic fatty liver disease insulin resistance metformin
an internet-delivered pain management programme for spinal cord injury pain

Conditions: Chronic Pain, Widespread; Spinal Cord Injuries

Summary: to establish the effectiveness of an internet-delivered cognitive behavioural therapy pain management programme (cbt-pmp) on people with spinal cord injury pain compared with usual care.

a pilot prospective, single blinded, randomised controlled trial with two arms an internet-delivered cbt-pmp for chronic pain post spinal cord injury (sci) and usual care. the cbt-pmp will contain 8 sessions over 8 weeks, with outcomes assessed at baseline, post intervention, and 6 months follow-up. participants will be adults with chronic pain (pain \> 3 months), regular internet access and not undergoing any other psychological treatments. following the study those in the intervention strand will be invited to complete a focus group to explore the subjects' overall experience of the online cbt-pmp.

Eligibility criteria:
inclusion criteria: * traumatic or non-traumatic sci * chronic sci pain of more than three months. * discharged from acute hospital and rehabilitation services. * males/females \>18years. * regular computer and internet access and working knowledge of the internet. * fluency in english (verbal and written). exclusion criteria: * those who have completed a pmp before * mental health issue which requiring psychiatric management. * acute injury, currently under specialist medical care. * patients with confounding co-morbidities such as cancer, unstable angina / uncontrolled cardiac arrhythmias/ severe aortic stenosis, acute systemic infection accompanied by fever, systemic/inflammatory diseases eg rheumatoid arthritis/substance abuse/significant mental health issues.
investigating hearing aid frequency response curves 2

Conditions: Hearing Loss, Sensorineural; Hearing Loss, Bilateral

Summary: internal research on the manufacturer's hearing aid products has idenitfied areas in which the investigators can improve the hearing aid frequency response curve. based on the conclusions of the first study, we have identified areas that require further analysis and testing prior to implementing of the proposed frequency response curve into our products. this study aims to investigate the current freqeuncy response curve in the manufacturer's products to variations of these curves to determine if hearing aid users prefer the variations over the manufacturer's standard curve.

internal testing has identified areas in which the investigators can improve the performance of the manufacturer's hearing aid products. this should potentially lead to increased hearing aid user satisfaction due to an improvement in sound quality and listener comfort. therefore, a study is proposed in which hearing aid users will compare the manufacturer's current frequency response curve to variations made to the curve and determine which one they prefer while listening to live speech/music or while streaming speech/music and while in different listening enviroments.

Eligibility criteria:
inclusion criteria: * n3 - n5 hearing losses * healthy outer ear * no visible congenital or traumatic deformity of the outer ear * symmetrical hearing loss - no air-bone gap greater than 10 db at all 500, 1000, 2000, and 4000 hz. * ability to answer questions and repeat sentences * no history of problematic tinnitus or pain/discomfort from loud sounds * no history of active drainage from the ears in the past 90 days * willingness to wear different styles of couplings * willingness to wear binaural fitting * experienced users = more than 3 months of hearing aid experience * ability to travel to sonova facilities exclusion criteria: * contraindications to the medical device (md) in this study (e.g. known hypersensitivity or allergy to the investigational products) * limited mobility/not able to come to the scheduled visit * inability to produce reliable hearing test results * history of active drainage from the ear in the previous 90 days * abnormal appearance of the eardrum and ear canal.

Keywords: hearing loss hearing aids frequency response curves
expression of irak1 gene rs1059703-related single- nucleotide polymorphisms in egyptian patient with rheumatoid arthritis

Conditions: Rheumatoid Arthritis (RA)

Summary: rheumatoid arthritis (ra) is known as a long-lasting inflammatory autoimmune disease affecting the diarthrodial joints, which is diagnosed by inflammation and hyperplasia in synovium, generation of rf and anti-citrullinated protein antibody (acpa), deformity of cartilage and bone, systemic injuries involving cardiovascular, pulmonary, psychological, and skeletal disorders (mcinnes and schett., 2011).


Eligibility criteria:
inclusion criteria: * approval to sign an informed written consent, patient diagnosed rheumatoid arthritis, patient age range 17-85 year and both sexes are included. exclusion criteria: * refusal to sign an informed written consent and patient with other autoimmune disease.
incidence, risk factors, predictors and survival for neurological complications after liver transplantation

Conditions: Liver Transplant; Complications; Neurologic Complication; Postoperative Complications

Summary: liver transplantation is the definitive treatment in patients with chronic liver disease. neurological complications (nc) occur commonly after liver transplantation. the investigators aim to evaluate the incidence, risk factors and predictors of neurological complications in both living donor and deceased donor transplantation done in the hospital. between january 2011 to december 2016, 253 liver transplant recipients were recruited for this study. the investigators recorded the incidence of neurological complications, their median time of onset, their relationship with etiology of chronic liver disease, and the risk factors for the complications. the investigators also studied the relationship of neurological complications with duration of hospital and icu stay, and survival. using multivariate forward regression analysis , the investigators developed a scoring system for prediction of neurological complications in liver transplantation.


Eligibility criteria:
inclusion criteria: * patients undergoing liver transplant surgery * 18-65 years exclusion criteria: * pregnant patients * acute liver failure, acute on chronic liver failure

Keywords: liver transplantation neurological complications postoperative complications
testing the effectiveness of a parent and child mindfulness-based intervention for child venipuncture

Conditions: Pain; Needle Stick

Summary: this study investigates the impact of mindfulness-based intervention for children undergoing a blood-draw and their accompanying parent on (a) child ratings of pain and fear, (b) parent and child ratings of parent distress, and (c) parent perceptions of child pain and fear. half of the parent-child pairs will receive the mindfulness-based intervention, while half will receive an unfocused-attention task to serve as a comparison with no active component.

to date, there are no randomized controlled trials (rct) involving a mindfulness intervention for pediatric acute pain. moreover, this will be the first study to investigate a parent mindfulness intervention in the context of child acute pain. within a randomized control trial, the objectives of this study are to test the effectiveness of a mindfulness-based intervention for children undergoing a venipuncture and their accompanying parent on (a) child ratings of pain and fear, (b) parent and child ratings of parent distress, and (c) parent perceptions of child pain and fear. participants will complete questionnaires immediately before and after child venipuncture. this study aims to offer a novel intervention that may improve both parent and child experience during a stressful situation in which parent and child unmanaged distress has deleterious effects. the long-term objectives of this line of research are to improve extant pain management interventions for children undergoing needle-pokes or other painful procedures. moderator aims: to identify possible moderators of a differential treatment outcome (parent and child responses during the needle-poke). these psychological factors include parent and child state catastrophizing, trait experiential avoidance, and trait mindfulness which will be investigated as moderators of the impact of experimental group on the primary outcomes of child self-reported pain and fear, and secondary outcome of parent self-reported distress.

Eligibility criteria:
inclusion criteria: * proficiency in english exclusion criteria: * major developmental delays in child

Keywords: pain management children parents mindfulness
effect of creatine on serum and urine creatinine

Conditions: Acute Kidney Injury

Summary: background: creatinine (crn) concentration is used to assess renal function via calculation of gfr (glomerular filtration rate). by rifle (risk, injury, failure, loss, end stage kidney disease) criteria, acute kidney injury (aki) and acute renal failure (arf) are defined by a two-fold and three-fold increase in serum crn, respectively. crn is a breakdown product of proteins and circulating creatine, and it is generally a benign product present in serum. creatine is a nutritional supplement that has been available since 1993, and it is widely used among athletes today. methods: in an irb approved, blinded crossover trial, 25 human volunteers ingested 2 creatine supplements to determine any associated statistically significant increase in serum crn and clinically significant increase in serum crn to a degree associated with aki or arf. urine samples were also collected to examine excretion patterns after an ingested sample. participants ingested 10 gm of creatine ethyl ester (cee) or creatine monohydrate (crm) and had serum crn assayed at 0, 1, 2, 3, 4, 5 and 24 hours. urinary crn levels were assayed at 0, 1.5, 3, 5 and 24 hours. exclusion factors were any history of renal disease or use of creatine within the last month. statistical analysis was performed by wilcoxon matched-pair signed ranks test and descriptive summary statistics were performed.


Eligibility criteria:
inclusion criteria: * age over 18 * human exclusion criteria: * use of any form of creatine within 4 weeks prior to participation in study. * pregnancy * history of elevated creatinine or renal insufficiency * history of pku

Keywords: creatine creatinine serum creatinine urine creatinine creatine monohydrate creatine ethyl ester acute kidney injury renal kidney
non-interventional-study with tacrolimus sandoz© capsules for prophylaxis of renal graft rejection

Conditions: Chronic Kidney Insufficiency

Summary: this non-interventional study intends to collect epidemiological data in patients with stable kidney function after renal transplantation, who receive tacrolimus sandoz© according to the approved indication.


Eligibility criteria:
inclusion criteria: * age: ≥ 18 * post renal transplantation time: ≥ 6 months * stable kidney function ( serum creatinine \< 3.0mg/dl; variation \< 0.5mg/dl at 2 appointments in minimum distance of 6 days) * stable tacrolimus sandoz© dose \> 2 weeks before inclusion in this non interventional study (nis) * written and oral informed consent exclusion criteria: * well-known poor compliance with immunosuppressives * acute rejection reaction within the past 3 months or antibody-therapy because of rejection within the past 6 months

Keywords: grafting, kidney transplantation, kidney
rewards-angina at follow up post stenting

Conditions: Rate of Angina

Summary: single center, retrospective registry to collect data regarding the rate of angina (any and ccs clas iii/iv) within 12 months post stent implantation. in addition, the target vessel revascularization rate within 12 months post stent implantation.

the objective of this study is to retrospectively identify the rate of angina (any as well as ccs class iii/iv) up to one (1) year following stent implantation. the following drug eluting stents will be evaluated in addition to bare metal stents; cypher, taxus express, xience v, resolute and promus element. the target vessel revascularization rate will also be compared for the 6 stent types within one (1) year.

Eligibility criteria:
inclusion criteria: * patients, male or female, \> 18 years of age, * patients who received at least one (1) commercially available drug eluting stent or bare metal stent: cypher, taxus express, xience v, promus element, resolute, or bare metal stents exclusion criteria: * received more than one type of des as listed above or both a bms and des (as listed above)